510(k) K191595 ยท MMI Immunoassay Method, Troponin Subunit
ARCHITECT STAT High Sensitivity Troponin-I
| Applicant | Abbott Laboratories Diagnostics Division, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Jun 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191595
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.